UTHR-promising FDA recognition news from last year
Silver Spring, MD and Research Triangle Park, NC, November 9, 1998: United
Therapeutics Corporation announced today that the U.S. Food and Drug Administration
(“FDA”) approved its application for a $400,000 grant toward the expenses of developing
its drug UT-15 for the treatment of a rare disease called primary pulmonary hypertension
(“PPH”). The FDA grant was issued under its Orphan Drug Grant Program for financial
assistance to companies developing promising drugs for diseases afflicting fewer than
200,000 persons in the United States (“orphan diseases”).
“We are excited to receive this recognition from the FDA for our efforts to improve
treatment for pulmonary hypertension,” said Martine Rothblatt, Chairman & CEO of
United Therapeutics. “We are working hard to make our therapy available to patients by
2001, and the FDA's orphan drug grant will certainly help.”
Approximately 50,000 people are estimated to be diagnosed with life threatening
pulmonary hypertension. Many of these patients are said to have developed the disease
as a result of taking the diet drugs Redux and Phen-fen. Although patients are typically
women in their 20s and 30s, left untreated, mean survival for PPH patients is less than
three years. The primary therapies for these patients today are lung transplants or life-long,
24 hour-a-day intravenous infusion of a drug called prostacyclin. United
Therapeutics' UT-15 therapy is intended to be a safer subcutaneous formulation of
prostacyclin.
“United Therapeutics is working with the world's pulmonary hypertension experts in
developing UT-15 for patients with PPH. This will be a very important drug for people
with Pulmonary Hypertension,” said Dr. James W. Crow, President and Chief Operating
Officer of United Therapeutics.
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